Today on Pharmaceutical Processing
American College of Clinical Pharmacology cautions against widespread off-label use of ketamine
Interest in the dissociative anesthetic ketamine is surging, given its potential to treat treatment-resistant depression and other mental health disorders. Against that backdrop, the American College of Clinical Pharmacology (ACCP) have released two policy statements advocating for stricter use of the drug. In addition, ACCP is arguing against its use in non-medical settings such as…
Daiichi-Sankyo to close Plexxikon unit
A decade ago, Daiichi-Sankyo (TYO:4568) announced its plan to acquire small molecule pharmaceutical specialist Plexxikon for $935 million. Now, the company has announced a reorganization of its R&D structure that involves closing the R&D subsidiary Plexxikon on March 31, 2022. Plexxikon has approximately 60 employees. The unit was instrumental in developing two commercialized drugs, Zelboraf…
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Noble expands its services for its clients into Human FactorsHuman Factors + (HF+) is a natural extension of Noble’s deep understanding of the patient experience relative to self-administering drug…
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FDA postpones some inspectional activities amid omicron surge
The FDA announced earlier this week that it made some temporary changes to its inspectional activities due to COVID-19. With the omicron variant of the virus causing surges across the world, the FDA implemented the changes in the U.S. on Dec. 29, 2021, to ensure the safety of its employees and the firms it regulates,…
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Novo Nordisk settles Danish securities lawsuit
Novo Nordisk (NYSE:NVO) has settled a securities lawsuit in Denmark filed in August 2019 in the district court of Glostrup. In 2019, Novo Nordisk vowed to fight the allegations contained in the lawsuit, which alleged that the company’s insulin-related profits fell at the same time prices and sales increased from February 2015 and February 2017. The…
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Lessons in life or death logistics
The cell and gene therapy market continues to advance, thanks to its potential to treat cancers and other severe diseases. While the pandemic has had a negative impact on companies specializing in cell and gene therapies, it has also catalyzed interest in cold-chain logistics while highlighting the promise of new therapy types. Organizations interested in…
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Gilead identifies counterfeit versions of two of its HIV drugs
Gilead Sciences (NSDQ: GILD) has announced that it has identified tampered and counterfeit versions of its HIV drugs Biktarvy and Descovy in the U.S. supply chain. Biktarvy is a blockbuster drug cocktail, raking up $7.26 billion in sales last year. 2020 sales of Descovy were $478 million. Foster City, Calif.–based Gilead said that unauthorized distributors…
